Senior Principal Associate, Molecule Process Quality - Lilly Medicine Foundry

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for individuals who are determined to make life better for people worldwide.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines while reducing costs and environmental impact.

The Small Molecule facility will be responsible for the manufacture of drug substance (DS) produced via organic synthesis, including traditional small molecule medicines at multiple scales as well as high potency antibody drug conjugates.

As the Foundry is currently in design and construction (startup phase anticipated completion in 2027), the initial position will be fluid and dynamic as we endeavor to support the delivery of the Foundry, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing facility.

Once Small Molecule startup activities are completed, the Small Molecule Process Quality function will provide on-site quality oversight of GMP operations.

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making and drive progress.
• Support the execution of the site operational readiness plan including development of early phase quality processes and operational procedures and controls.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross-functionally with the plant teams to develop processes, provide operational support, and issue management.
• Assist with inspection readiness activities.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.
• Participate in global communities of practice and committees, as appropriate, to establish and maintain a network for benchmarking and share learning.
• Identify and lead process improvement projects impacting multiple business areas.

• BA/BS degree in Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in Biotech or Pharmaceutical FDA regulated industry.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Experience in API manufacturing of synthetic small molecules and/or high potent antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in high paced working environment.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Demonstrated strong oral and written communication skills.
• Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
• Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
• Ability to input and influence decision making for complex technical issues.
• Ability to establish key relationships and influence peers and business partners.
• Ability to identify and prioritize issues and develop & implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Demonstrated attention to detail.

• Position Location:
  
  US:
  Lebanon IN Lilly Medicine Foundry Operations; initial location in Indianapolis, IN during startup phase
• Travel Percentage: 5% - 15%
• May be required to provide on-call support outside of normal working hours including nights,…